How safe are mental health medications? It's probably not surprising that they may not be quite as safe as a placebo. An October 2005 meta analysis (which looked at multiple studies that had been done in the past) found that patients with dementia who took atypical antipsychotic drugs had a slightly increased risk of death compared to patients who took placebo. The study was published in the October 19th issue of the Journal of the American Medical Association. It is important to keep in mind that this study looked at elderly patients with dementia, rather than patients diagnosed with schizophrenia or bipolar disorder. These elderly patients are more vulnerable than a younger population, and they tend to have more side effects when they take any medications.
Elderly patients with dementia often develop aggression, delusions, and other mental health symptoms. Antipsychotic medications are commonly used to treat these behaviors, along with psychosocial and environmental interventions. During the last decade, newer atypical antipsychotic drugs (such as risperidone, olanzapine, quetiapine, and aripiprazole) have largely replaced the older conventional or first generation antipsychotic drugs (such as haloperidol and thioridazine). Some have raised concerns about possibly increased risks for cerebrovascular adverse events, rapid cognitive decline, and death with these mediations.
The study by Lon Schneider, M.D., and colleagues selected 15 trials which were generally 10 to 12 weeks in duration, including 16 contrasts of atypical antipsychotic drugs with placebo. A total of 3,353 patients were randomized to study drug and 1,757 were randomized to placebo. Death occurred more often among patients randomized to drugs (118 [3.5 percent] vs. 40 [2.3 percent]). This difference was statistically significant - meaning that the result is very unlikely to have been due to chance. No differences were found among the different drugs.
The authors conclude that "These findings emphasize the need to consider certain changes in some clinical practices. Antipsychotic drugs have been dispensed fairly frequently to patients with dementia and used for long periods. The established risks for cerebrovascular adverse events together with the present observations suggest that antipsychotic drugs should be used with care in these patients. The fact that excess deaths and cerebrovascular adverse events can be observed within 10 to 12 weeks of initiating medication, coupled with observations from individual clinical trials results that there is substantial improvement in both drug and placebo groups during the first 1 to 4 weeks of treatment, lead to the consideration that antipsychotic drugs should be prescribed and dosage adjusted with the expectation of clinical improvement within that time. If improvement is not observed, the medication could be discontinued."
What does this mean for patients who are taking these medications for schizophrenia or bipolar disorder? Someone will need to do another study with that population before we know for sure. Almost any medication given daily over an extended time could result in more deaths than placebo in an elderly population. If you are taking one of these medications for a mental health condition you should continue to take your medications. Talk to your doctor if you have any concerns about the recent study. If you are elderly and taking one of these medications you may especially want to discuss this with your doctor.
